NCT06226909

Brief Summary

To investigate the information from shear-wave elastography on pleural tissues will improve the diagnosis of pleural diseases, as to increase the diagnostic yield in ultrasound-guided transthoracic pleura biopsy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jan 2024Aug 2027

Study Start

First participant enrolled

January 15, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

3.6 years

First QC Date

January 17, 2024

Last Update Submit

January 30, 2024

Conditions

Pleural Diseases

Outcome Measures

Primary Outcomes (1)

  • The diagnostic yield of the two groups

    the pathology of pleural biopsies will be interpreted by cytopathologists

    6 months

Secondary Outcomes (2)

  • Procedure time

    1 day

  • the rate of pneumothorax & hemothorax

    1 day

Study Arms (2)

Shear-wave elastography-guided

EXPERIMENTAL

based on the shear-wave elastography, the area with the highest elasticity value will be the target area to perform pleural biopsy for at least 6 times

Procedure: different types of ultrasound technique

B-mode ultrasound-guided

ACTIVE COMPARATOR

based on the B-mode transthoracic ultrasound, the area with the maximal thickness will be the target area to perform pleural biopsy for at least 6 times

Procedure: different types of ultrasound technique

Interventions

different types of ultrasound techniquePROCEDURE

Shear-wave elastography-guided or B-mode ultrasound-guided

B-mode ultrasound-guidedShear-wave elastography-guided

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with radiographic evidence of pleural disease

You may not qualify if:

  • Age \< 18 y/o
  • Patients who cannot hold their breath for 5 seconds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Yao-Wen Kuo

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao-Wen Kuo

CONTACT

0972651821kyw@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 26, 2024

Study Start

January 15, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)